UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Securities registered pursuant to Section 12(b) of the Act: For the quarterly period ended October 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission File Number 001-40854 NUTRIBAND INC. (Exact name of registrant as specified i ...

Core Points - Nutriband Inc. will have its Chairman and Co-Founder, Serguei Melnik, present at NobleCon21 on December 3rd, 2025, at 9:30 AM Eastern Standard Time [1] - Interested investors can attend the conference at a discounted rate using the code NTRBNOBLECON [2] - A high-definition video webcast of the presentation will be available the following day and archived for 90 days [3] Company Overview - Nutriband Inc. focuses on developing transdermal pharmaceutical products, with its lead product being an abuse-deterrent fentanyl patch utilizing AVERSA™ technology [4] - AVERSA™ technology aims to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential [4] Noble Capital Markets - Noble Capital Markets, established in 1984, is a full-service broker-dealer providing investment and advisory services, with a strong research team and a proprietary research distribution platform [6] - Noble has raised billions of dollars for companies and published over 45,000 equity research reports [6] Channelchek - Channelchek, launched in 2018, is an investor community dedicated to emerging growth public companies, offering free institutional-quality research and advanced market data [7]

Core Viewpoint - Nutriband is advancing its lead product, AVERSA™ FENTANYL, an abuse-deterrent transdermal system, following a constructive meeting with the US FDA to discuss its Chemistry, Manufacturing, and Controls (CMC) plans, aiming for an Investigational New Drug (IND) filing to support a Human Abuse Potential clinical study [2][4][6] Group 1: FDA Meeting Outcomes - The FDA provided feedback on the CMC plans from IND submission to 505(b)(2) New Drug Application (NDA) approval [3][6] - The FDA acknowledged the importance of addressing fentanyl patch abuse and offered ongoing support during the development program [4][5] - Nutriband's product has the potential to be the first abuse-deterrent fentanyl patch approved globally, addressing a significant unmet medical need [4][10] Group 2: Product Development and Market Potential - AVERSA™ FENTANYL is designed for pain management in opioid-tolerant patients requiring long-term opioid treatment [2][3] - The product is projected to achieve peak annual US sales between $80 million to $200 million, with plans to expand into major global markets [10] - Nutriband's AVERSA™ technology incorporates aversive agents to enhance the safety profile of transdermal drugs susceptible to abuse [9][12] Group 3: Intellectual Property and Partnerships - The AVERSA™ technology is protected by a broad international intellectual property portfolio with patents issued in 46 countries [11][12] - Nutriband is collaborating with Kindeva to develop AVERSA™ FENTANYL, combining its technology with Kindeva's FDA-approved fentanyl patch [8][9]

Core Viewpoint - Nutriband is advancing its lead product, AVERSA™ FENTANYL, an abuse-deterrent transdermal system, following positive feedback from the US FDA regarding its Chemistry, Manufacturing, and Controls (CMC) plans, aiming for an Investigational New Drug (IND) filing to support a Human Abuse Potential clinical study [2][3][4]. Product Development - The FDA meeting on September 18, 2025, provided critical feedback for the development program, focusing on the CMC plans from IND submission to 505(b)(2) New Drug Application (NDA) approval [2][3]. - Nutriband is incorporating FDA feedback into its development program, which is essential for the upcoming IND filing [4]. - The FDA acknowledged the significant issue of fentanyl patch abuse and offered ongoing support and guidance throughout the development process [3]. Market Potential - AVERSA™ FENTANYL has the potential to achieve peak annual US sales between $80 million to $200 million, with plans to address unmet medical needs for pain management globally [7]. - The product aims to be the first abuse-deterrent fentanyl patch approved worldwide, addressing a critical gap in the market [3][6]. Technology and Partnerships - Nutriband's AVERSA™ technology incorporates aversive agents into transdermal patches to mitigate abuse, misuse, and accidental exposure, enhancing the safety profile of drugs like fentanyl [6][10]. - The company is collaborating with Kindeva to develop AVERSA™ FENTANYL, combining its technology with Kindeva's FDA-approved fentanyl patch [5]. Regulatory Pathway - The FDA confirmed that the regulatory pathway for AVERSA™ FENTANYL is a 505(b)(2) NDA, providing guidance on the reference listed drug and bridging strategy [7]. - The FDA also discussed expectations for the registration batch plan and manufacturing process validation strategy for NDA submission [7].

Core Viewpoint - Nutriband is advancing its lead product, AVERSA™ FENTANYL, an abuse-deterrent transdermal system, following positive feedback from the US FDA regarding its Chemistry, Manufacturing, and Controls (CMC) plans, aiming for an Investigational New Drug (IND) filing to support a Human Abuse Potential clinical study [2][3][4]. Company Developments - Nutriband held a virtual meeting with the FDA on September 18, 2025, to discuss the CMC aspects of AVERSA™ FENTANYL, which is intended for pain management in opioid-tolerant patients [2][3]. - The FDA provided constructive feedback on the registration batch plan, manufacturing process validation strategy, and product specifications for the 505(b)(2) New Drug Application (NDA) submission [7][3]. - Nutriband is collaborating with Kindeva to develop AVERSA™ FENTANYL, integrating its abuse-deterrent technology with Kindeva's FDA-approved fentanyl patch [5][11]. Market Potential - AVERSA™ FENTANYL has the potential to achieve peak annual sales in the US ranging from $80 million to $200 million, addressing a significant unmet medical need for effective pain management [7]. - The technology is protected by a broad international intellectual property portfolio, with patents issued in 46 countries, enhancing its market position [8][10]. Product Features - The AVERSA™ abuse-deterrent technology aims to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential, particularly opioids like fentanyl [6][10]. - The FDA acknowledged the importance of addressing fentanyl patch abuse and offered ongoing support and guidance throughout the development process [3][4].

Core Points - Nutriband Inc. has announced the return of founder Gareth Sheridan as CEO, effective immediately, after Serguei Melnik temporarily took over the role from August 10 to October 27, 2025 [1] - The company is focused on advancing its lead product, AVERSA Fentanyl, towards a target NDA filing in 2026 [1] Group 1: Product Overview - AVERSA Fentanyl is positioned to be the world's first abuse-deterrent opioid patch, aimed at preventing abuse and reducing accidental exposure risks associated with transdermal fentanyl patches [2] - The product has the potential to achieve peak annual sales in the US ranging from $80 million to $200 million, with plans to expand into major global medical markets [2] Group 2: Technology and Intellectual Property - The AVERSA abuse-deterrent technology is protected by a comprehensive international intellectual property portfolio, with patents issued in 46 countries, including the US, Europe, Japan, and China [3] - This technology incorporates aversive agents into transdermal patches to mitigate the risks of abuse, misuse, and accidental exposure while ensuring accessibility for patients in need [3][4] Group 3: Company Background - Nutriband Inc. specializes in developing a range of transdermal pharmaceutical products, with AVERSA Fentanyl being the lead product under development [4] - The AVERSA technology can be integrated into any transdermal patch to enhance safety and prevent misuse of drugs with abuse potential [4]

Core Insights - Nutriband has initiated the development of a worldwide brand name for its lead product, an abuse-deterrent fentanyl transdermal system, in partnership with Brand Institute, Inc [1][10] - The AVERSA™ FENTANYL product aims to be the first abuse-deterrent opioid patch, designed to prevent misuse and accidental exposure to fentanyl [2][6] Company Overview - Nutriband is focused on developing transdermal pharmaceutical products, with its lead product being an abuse-deterrent fentanyl patch utilizing AVERSA™ technology [8] - The AVERSA™ technology incorporates aversive agents into transdermal patches to mitigate the risks of abuse and accidental exposure [6][7] Brand Development - Developing a proprietary brand name is crucial for distinguishing the product from similar-sounding or looking drug names, which can prevent medication errors [3] - Brand Institute holds a significant market share, with a 75% approval rate for drug names globally, including 87% of FDA-approved names in 2024 [4][10] Regulatory Support - Drug Safety Institute, a subsidiary of Brand Institute, will provide regulatory services for the project, staffed by former officials from major health agencies [5][10] - The expertise of Drug Safety Institute includes co-authoring naming guidance documents, ensuring safety and preventing medication errors [5][10]

Key Points - Several biotech stocks experienced notable after-hours gains on October 9, driven by new data and corporate developments [1] Company Summaries Palisade Bio Inc. (PALI) - Shares traded at $2.26 in after-hours, reflecting a 7.62% gain from the prior close of $2.10, which was up 5% on the day [1] - The company cancelled its special meeting of stockholders due to lack of quorum, withdrawing all proposals from consideration [2] Healthcare Triangle Inc. (HCTI) - Shares traded at $2.88 in after-hours, up 4.35% from the regular session close of $2.76, which was down 17.86% [3] - The company signed a non-binding Letter of Intent to acquire Teyame.AI, projected to generate $34 million in revenue for fiscal year 2025 [4] Nutriband Inc. (NTRB) - Shares traded at $8.25 in after-hours, up 4.30% from the regular session close of $7.91, which was down 6.94% [5] - The company filed a provisional patent application with the USPTO to strengthen its intellectual property for its AVERSA abuse deterrent transdermal [5] Karyopharm Therapeutics Inc. (KPTI) - Shares traded at $6.08 in after-hours, up 4.46% from the regular session close of $5.82, which had declined 1.36% [6] - The company announced financing transactions expected to provide $100 million in financial flexibility, extending its cash runway into Q2 2026 [6] Editas Medicine Inc. (EDIT) - Shares traded at $4.22 in after-hours, up 3.43% from the regular session close of $4.08, which was down 1.69% [7] - The company presented new preclinical proof-of-concept data for its therapy EDIT-401, showing a 90% LDL-C reduction in non-human primates and mice [7] CG Oncology Inc. (CGON) - Shares traded at $45.40 in after-hours, up 2.11% from the regular session close of $44.46, which gained 9.21% [8] - No official news releases or filings were issued during the day [8]

Core Viewpoint - Nutriband Inc. has filed a provisional patent application to enhance its AVERSA™ transdermal abuse deterrent technology aimed at preventing the misuse of opioids and stimulants [1][2]. Group 1: Patent Application and Technology - The provisional patent application focuses on improved aversive formulations and coating methods to strengthen the abuse deterrent properties of the AVERSA™ technology [2]. - If converted to a non-provisional patent, it could extend patent protection for products utilizing AVERSA™ for 20 years from the non-provisional filing date [2]. - The AVERSA™ technology is protected by a broad international intellectual property portfolio with patents issued in 46 countries, including the U.S., Europe, Japan, and China [3]. Group 2: Technology Applications and Benefits - AVERSA™ technology incorporates aversive agents into transdermal patches to prevent abuse, diversion, misuse, and accidental exposure of drugs with abuse potential, such as opioids and stimulants [4][5]. - This technology aims to improve the safety profile of transdermal drugs while ensuring accessibility for patients who genuinely need them [4][5]. Group 3: Company Overview - Nutriband Inc. is primarily focused on developing a portfolio of transdermal pharmaceutical products, with its lead product being an abuse-deterrent fentanyl patch utilizing AVERSA™ technology [6].

ORLANDO, Fla., Oct. 08, 2025 (GLOBE NEWSWIRE) -- Nutriband Inc. (NASDAQ: NTRB) (NASDAQ: NTRBW), today announced that its Chairman Serguei Melnik will present at Noble Capital Markets’ Emerging Growth Virtual Equity Conference on Wednesday, October 8 at 15:00 Eastern Standard Time. The formal presentation will feature a fireside style Q&A session with questions welcome from the live virtual audience. Scheduled 1x1 meetings with Mr. Melnik are also available for registered, qualified investor attendees. Atten ...